Field
This disclosure relates generally to the field of catheters for draining the urinary bladder.
Description
A urinary bladder tube is used in certain patients who have undergone major surgery, or any patient who is unable to urinate. There are many causes for inability to urinate. These causes differ with age and sex. For example, a small child may not urinate because of some congenital abnormality obstructing the bladder neck or urethra. In females, inability to urinate occurs in neurological diseases, after delivery of a baby, or after major abdominal or pelvic surgery. In a male, the most common causes of inability to urinate are an obstructing prostate, neurological diseases, or after major abdominal or pelvic surgery.
It can be desirable to continuously drain the bladder after major surgery at least for the purpose of monitoring the hourly urine output. It is also desirable to continuously drain the bladder by an indwelling Foley catheter in medical conditions where the measurement of hourly urine output is important to the well-being of the patient.
It can also be desirable to drain the bladder by an indwelling catheter after prostate or bladder surgery. Diverting the urine and blood will promote fast healing and prevent clots from building up in the bladder, which often cause more bleeding and severe pain.
It can also be important to drain the bladder by an indwelling catheter for pelvic surgeries. By draining the bladder, the operating space in the pelvis can be increased and it can facilitate access to structures such as the uterus in female patients.
It is also recognized that it can be recommended in clinical practice after pelvic surgeries to conduct an assessment of the bladder and ureters to ensure that no damage to these organs has occurred. In many cases an optimal way for making this assessment is the use of a cystoscope where the internal surface of the bladder can be viewed as well as the vesicoureteral junction. The vesicoureteral junction can be observed to look for flow of urine into the bladder indicating that no impairment of the ureters, bladder, or other structures has occurred during the surgery. In some cases, use of an intravenous dye such as indigo carmine can be used to visualize urinary tract flow and determine possible leakage. In the U.S. today, there are over 1 million gynecologic pelvic procedures performed each year. The incidence of urologic injury has been reported to range from 1 to 3%. During laparoscopic hysterectomy, the incidence of ureteral injury has been reported at 0.2 to 4.3%. Reoperation, when necessary if an undetected injury has occurred, carries an average expense of $8,000-$12,000. Today, many surgeons defer the urologic assessment due to costs, risks, inconvenience and the additional time required.
Currently, cystoscopy is performed through a 3 piece rigid metal system which needs assembly and availability of reusable sterilized equipment in the operating room. The procedure has remained largely unchanged for over 3 decades. The system is cumbersome, complicated, expensive, and not always available. In addition, it requires increased time of catheter removal and cystoscope assembly as well as multiple instances of urethral instrumentation, increasing risk of infection and urethral trauma. Systems and methods as disclosed herein can obviate these shortcomings.
In certain bladder or prostate surgeries, continuous bladder irrigation is used. This is achieved by introducing fluid continuously into the bladder and simultaneously draining the bladder. This type of Foley catheter is called a three-way catheter. One port will serve as fluid irrigation port into the bladder. The second port is for continuous drainage of the bladder contents into a large urine bag. The third port is for a valve mechanism where a balloon is inflated inside the bladder to keep the tip of the Foley catheter indwelling inside the bladder.
In certain patients, the bladder must be drained for many years, such as debilitated patients or those with neurological or spinal cord lesions. If the bladder is not drained, the pressure in the bladder will build up and the kidneys will be obstructed. Continuous bilateral kidney obstruction may lead to renal failure.
Therefore, the use of an indwelling catheter can be clinically advantageous, and could be life-saving, both in an acute and chronic long term settings. Some examples of Foley catheters are disclosed, for example, in U.S. Pat. No. 5,810,790 to Ebling et al. and U.S. Pat. No. 6,096,013 to Hakky et al., which are hereby incorporated by reference herein in their entireties.